MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-21 for SAVOY DILATOR UNKNOWN manufactured by Wilson Cook.
[16294096]
Patient underwent esophageal dilation. A perforation of esophagus occurred necessitating exploratory thoractomy and repair of esophagus.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 17305 |
| MDR Report Key | 17305 |
| Date Received | 1994-07-21 |
| Date of Report | 1994-06-03 |
| Date of Event | 1994-05-26 |
| Date Facility Aware | 1994-05-26 |
| Date Added to Maude | 1994-11-01 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SAVOY DILATOR |
| Generic Name | DILATOR/GUIDEWIRE |
| Product Code | KCF |
| Date Received | 1994-07-21 |
| Model Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 17237 |
| Manufacturer | WILSON COOK |
| Manufacturer Address | 4900 BETHANIA STATION ROAD WINSTON-SALEM NC 27105 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-07-21 |